Legal analysis: (a) Selection of the inspection team. The inspection team is generally composed of more than two personnel engaged in the supervision of medical devices or with the medical device production quality management standard inspector qualification, if necessary, relevant experts can be invited to participate.
(2) According to the cause of the implementation of flight inspection, and reference to the relevant information in the daily supervision file of the enterprise, in accordance with the requirements of the relevant laws and regulations and documents, to develop a detailed and targeted inspection program.
(iii) Determine the inspection time.
(iv) Fill in the flight inspection assignment (format see Annex 1).
(v) Organize the inspection team to learn the discipline of supervision and inspection.
(F) If necessary, in due course, notify the next level of food and drug supervision and management department where the enterprise is located to select the relevant supervisory personnel to assist in the inspection as observers.
Legal basis: "Medical Device Manufacturing Enterprises Flight Inspection Procedures" Article 6 Inspection preparation stage, the flight inspection organization is mainly to do the following work:
(a) Selection and dispatch of the inspection team. The inspection team generally consists of more than two personnel engaged in the supervision of medical devices or with medical device production quality management standard inspector qualification, if necessary, can invite relevant experts to participate.
(2) According to the cause of the implementation of flight inspection, and reference to the relevant information in the daily supervision file of the enterprise, in accordance with the requirements of the relevant laws and regulations and documents, to develop a detailed and targeted inspection program.
(iii) Determine the inspection time.
(iv) Fill in the flight inspection assignment (format see Annex 1).
(v) Organize the inspection team to learn the discipline of supervision and inspection.
(F) If necessary, when appropriate, notify the enterprise location of the next level of food and drug supervision and management departments to select the relevant supervisory personnel as observers to assist in the inspection.